Testing a B-vitamin supplement to reduce optic disc edema in astronauts
B-Complex: A Nutraceutical SANS Countermeasure
This study is testing if a daily B-vitamin supplement can help astronauts reduce swelling in their eyes during long space missions.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 20 Years to 100 Years |
| Sex | All |
| Sponsor | National Aeronautics and Space Administration (NASA) Federal |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05366933 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a daily nutraceutical supplement containing bioactive B vitamins to mitigate optic disc edema in astronauts during long-duration space missions. The approach focuses on optimizing the one-carbon metabolic pathway to enhance endothelial function and collagen elasticity, potentially minimizing retinal thickness changes. The study will involve comprehensive assessments of ocular health, vascular function, and nutritional status through blood sample analyses and other health metrics collected at various time points before and after spaceflight.
Who should consider this trial
Good fit: Ideal candidates for this study are astronauts selected for 6-12 month missions on the International Space Station.
Not a fit: Patients currently taking B-vitamin supplements will not benefit from this study.
Why it matters
Potential benefit: If successful, this could improve ocular health and overall vascular function in astronauts, enhancing their performance and safety during space missions.
How similar studies have performed: While this approach is innovative, similar studies have not been widely conducted, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Must be astronauts selected for 6-12 month missions on the International Space Station Exclusion Criteria: • Subjects taking B-vitamin supplements
Where this trial is running
Houston, Texas
- Johnson Space Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sara R Zwart, PhD — Utmb
- Study coordinator: Sara Zwart, PhD
- Email: sara.zwart-1@nasa.gov
- Phone: 2814833753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.